EP1550421B1 - Mehrteiliges Bauteil für ein orthopädisches Implantat - Google Patents

Mehrteiliges Bauteil für ein orthopädisches Implantat Download PDF

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Publication number
EP1550421B1
EP1550421B1 EP04258149A EP04258149A EP1550421B1 EP 1550421 B1 EP1550421 B1 EP 1550421B1 EP 04258149 A EP04258149 A EP 04258149A EP 04258149 A EP04258149 A EP 04258149A EP 1550421 B1 EP1550421 B1 EP 1550421B1
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EP
European Patent Office
Prior art keywords
component
portions
bearing
tibial
intercondylar
Prior art date
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Expired - Lifetime
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EP04258149A
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English (en)
French (fr)
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EP1550421A1 (de
Inventor
Michael E. Hawkins
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Zimmer Technology Inc
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Zimmer Technology Inc
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Publication date
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Priority to EP06003272A priority Critical patent/EP1656909B1/de
Publication of EP1550421A1 publication Critical patent/EP1550421A1/de
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0015Kidney-shaped, e.g. bean-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0057Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis made from both cured and uncured parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00203Ceramics or ceramic-like structures based on metal oxides containing alumina or aluminium oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures
    • A61F2310/00185Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00239Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2

Definitions

  • the present invention relates to orthopaedic implants. More particularly, the present invention relates to articular bearing surfaces for orthopaedic implants.
  • an orthopaedic knee implant may include a femoral component for replacing the femoral articulating condyles and a tibial component for replacing the tibial articulating surface.
  • the femoral component typically includes a metallic articulating bearing surface which glides and pivots on a non-metallic articulating bearing surface of the tibial component.
  • knee implants comprise a femoral component made of a metal such as Ti-6Al-4V alloy or Cobalt-Chromium-Molybdenum alloy and a tibial bearing surface made of ultra high molecular weight polyethylene (UHMWPE).
  • a femoral component made of a metal such as Ti-6Al-4V alloy or Cobalt-Chromium-Molybdenum alloy
  • a tibial bearing surface made of ultra high molecular weight polyethylene (UHMWPE).
  • UHMWPE ultra high molecular weight polyethylene
  • the implant components may include constraint mechanisms to provide some degree of constraint to the motion permitted between the components. These constraint mechanisms may replace or augment natural constraint in the joint such as that provided by tendons and ligaments crossing the joint. These constraint mechanisms may provide the function of missing or damaged natural constraints.
  • the tibial articular surface may include a post that projects upwardly to interact with a cam and box formed on the femoral component to limit rotation, varus/valgus tipping, anterior/posterior translation, posterior rollback, and/or other parameters of knee motion.
  • Such constraint mechanisms may see significant bending, shear, and even impact loads within the limits of normal operation. Therefore, it is generally desirable for the constraint mechanism components to have high strength and toughness. Furthermore, the constraint mechanisms have limits to the permissible wear that can occur between contacting surfaces.
  • a particular type of implant has an articular bearing surface for which low wear is of prime importance and which further includes a constraint mechanism portion for which strength and toughness are of prime importance.
  • a posterior stabilized knee it is desirable for the articular condyles to exhibit low wear and the tibial post to exhibit high strength and toughness.
  • the present invention provides an implant for replacing an articulating bone end adjacent a skeletal joint as defined in claim 1 and a tibial bearing component for replacing a portion of the proximal tibial surface of a knee joint as defined in claim 3.
  • an implant in one aspect of the invention, includes first and second components to replace a portion of each of a pair of opposed articulating bone ends.
  • the second component has means for low friction articulation with the first component and means for engaging the first component to constrain the motion between the components.
  • the means for low friction articulation includes a first material exhibiting low wear and having a predetermined toughness value.
  • the means for engaging includes a second material having a predetermined toughness value higher than the means for low friction articulation.
  • a tibial bearing component for replacing a portion of the proximal tibial surface of a knee joint includes a first portion having a bearing surface.
  • the bearing surface has a region exhibiting low wear and has a first predetermined toughness value.
  • the tibial bearing component includes a second portion having an intercondylar region.
  • the intercondylar region has a region having a second predetermined toughness value that is greater than the first predetermined toughness value.
  • the first and second portions are joined together to form a tibial bearing component.
  • a tibial implant for a knee joint in another aspect of the invention, includes first and second bearing portions. Each of the first and second bearing portions includes an articular surface having a first predetermined toughness value. An intercondylar portion is interposed between the first and second bearing portions. The intercondylar portion has a second predetermined toughness value greater then the first predetermined toughness value of the bearing portions.
  • the articulating joint construction of the present invention may be used in implants for any articulating joint, including for example, the articulating joints of the skeletal system.
  • the construction may be incorporated into implants for the hip, knee, shoulder, vertebrae, elbow, wrist, ankle, jaw, and digits.
  • a tibial knee component is depicted, although it will be understood by those skilled in the art that this invention may be suitable for other applications as well.
  • FIGS. 1-3 illustrate a tibial knee component 10 including an articular bearing insert 12 and a supporting tray 14.
  • the tray 14 includes an upper portion 16 for receiving the bearing insert 12 and a stem extension 18 for insertion into the tibial bone to hold the tray 14 in place.
  • the bearing insert 12 is divided into three discrete portions including two outer condylar components 20 and an intercondylar component 22.
  • the condylar components 20 each include an articular surface 24 for low friction articulation with a femoral component (not shown).
  • the articular surfaces 24 may be made of UHMWPE. It is desirable to minimize the wear between the articular surfaces 24 and the femoral component.
  • the articular surfaces 24 may be made of relatively hard and/or brittle materials that exhibit low wear.
  • An example is highly crosslinked UHMWPE. This material easily meet the strength requirements for the articular surfaces 24 since the articular surfaces 24 are primarily loaded in compression.
  • chemicals and/or radiation to highly crosslink UHMWPE to improve its wear properties.
  • Various forms of irradiation may be used including gamma and electron beam irradiation.
  • UHMWPE medical devices are commonly irradiated to sterilize them.
  • the irradiation dose for sterilization is approximately in the range of 2.5-3.7 Mrad. This dose range may result in lightly cross linked UHMWPE, but it does not result in an appreciable improvement in wear characteristics.
  • non-ionizing radiation, ethylene oxide gas, and other non-crosslinking forms of sterilization may be used that result in non-crosslinked polyethylene.
  • the degree of crosslinking may be described in terms of the average molecular weight between crosslinks. For UHMWPE that has been gamma irradiated at low dose for sterilization purposes, the molecular weight between crosslinks is on the order of 8800 grams per mole.
  • the average molecular weight between crosslinks is on the order of 3000-4000 grams per mole.
  • Another way to describe the degree of crosslinking is in terms of swell ratio. In this measurement, a sample of the polyethylene is exposed to a solvent. As the sample absorbs the solvent, it swells. Crosslinks inhibit the swelling. Thus the ratio of the size of the swollen sample to its original size yields a measure of the degree of crosslinking. For UHMWPE that has been gamma irradiated at low dose for sterilization purposes, the swell ratio is on the order of about 3.68. For highly crosslinked polyethylene, the swell ratio is on the order of about 2.3.
  • the intercondylar component 22 includes a tibial eminence 26 for engaging a box and/or cam formed on the femoral component to constrain the amount of relative motion permitted between the femoral and tibial 10 components.
  • the tibial eminence 26 is subjected to a combination of loads including shear, bending, and impacts. Therefore, it is desirable for the tibial eminence 26 to be made of a material that is relatively tough and impact resistant.
  • the eminence may also be made of UHMWPE.
  • the condylar components 20 and intercondylar component 22 are made from materials having different properties tailored to the expected loading of the different components.
  • the condylar components 20 may be made of materials that exhibit relatively low wear. This wear is typically quantified by measuring the weight loss exhibited by articulating components.
  • the intercondylar components may be made of materials that exhibit relatively high toughness. Toughness may be described as the amount of energy required to cause a material to fail.
  • One measure of toughness is fracture impact toughness measured by determining the amount of energy required to break notched samples with a calibrated pendulum.
  • Tensile failure toughness can be gauged by measuring the area under a load/displacement curve.
  • the condylar components 20 may be made of highly crosslinked UHMWPE while the intercondylar component 22 may be made of lightly or non-crosslinked UHMWPE.
  • the condylar components 20 and intercondylar component 22 may be joined together to form the tibial bearing insert 12 in a variety of ways.
  • the components may be provided as a modular kit of parts that are joined together intraoperatively by the surgical staff to permit customizing the implant to a particular patients needs.
  • the components may be permanently joined together at the time of manufacturing and supplied as a one piece tibial bearing insert 12.
  • the components may be permanently joined by bonding, by press fitting, or by molding them together in an interdigitating manner.
  • the components may be press fit into the tray 14 to keep them in their proper relative positions.
  • the components may be joined by mechanical fasteners.
  • the tray may be omitted and the tibial bearing insert 12 configured to be placed directly on the tibial bone.
  • the condylar components 20 and intercondylar component 22 are joined together with pins 28 press fit into the components perpendicular to the junction 30 between the components.
  • pins or splines 32 are pressed into the components parallel to the junction 30 between them.
  • FIG. 5 depicts a variation in which the intercondylar component 22 includes dovetail projections 34 and the condylar components include dovetail slots 36.
  • the condylar components 20 and intercondylar component 22 are joined together by engaging the dovetail projections 34 with the dovetail slots 36.
  • FIG. 6 depicts an illustrative embodiment in which the intercondylar component 38 includes the tibial tray 40 as a unitary extension.
  • the tray includes a support surface 42 for receiving the condylar portions 44.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Claims (10)

  1. Implantat (10) zum Ersetzen gegenüberliegender Gelenkknochenenden, die einem Skelettgelenk benachbart sind, wobei das Implantat aufweist:
    eine erste Komponente, um einen Abschnitt eines der gegenüberliegenden Gelenkknochenenden zu ersetzen;
    eine zweite Komponente (12), um einen Abschnitt des anderen der gegenüberliegenden Gelenkknochenenden zu ersetzen, wobei die zweite Komponente (12) eine Einrichtung (24) zur reibungsarmen Gelenkverbindung mit der ersten Komponente und eine Einrichtung (26) zur Ineingriffnahme der ersten Komponente aufweist, um die Bewegung zwischen den ersten und zweiten Komponenten zu beschränken, wobei die Einrichtung (24) zur reibungsarmen Gelenkverbindung ein erstes Material aufweist, das einen niedrigen Verschleiß aufweist und einen vorgegebenen Zähigkeitswert aufweist, und die Einrichtung (26) zur Ineingriffnahme ein zweites Material mit einem vorgegebenen Zähigkeitswert aufweist, der höher als jener der Einrichtung (24) zur reibungsarmen Gelenkverbindung ist, dadurch gekennzeichnet, daß entweder:
    (i) das erste Material vernetztes Polyethylen aufweist und das zweite Material unvernetztes Polyethylen aufweist; oder
    (ii) das erste Material verhältnismäßig hochvernetztes Polyethylen aufweist und das zweite Material verhältnismäßig gering vernetztes Polyethylen aufweist.
  2. Implantat nach Anspruch 1, wobei die Einrichtung (24) zur reibungsarmen Gelenkverbindung und die Einrichtung zur Ineingriffnahme (26) mechanisch verbunden sind, um eine einteilige Lagerkomponente zu bilden.
  3. Tibiale Lagerkomponente (12) zum Ersetzen eines Abschnitts der proximalen Tibiafläche eines Kniegelenks, wobei die Komponente aufweist:
    einen ersten Abschnitt (20) mit einer Lagerfläche (24), wobei die Lagerfläche (24) einen Bereich aufweist, der eine Lagerausführung mit einem niedrigen Verschleiß aufweist und einen ersten vorgegebenen Zähigkeitswert aufweist; und
    einen zweiten Abschnitt (22) mit einem interkondylären Bereich, wobei der interkondyläre Bereich einen Bereich (26) aufweist, der einen zweiten vorgegebenen Zähigkeitswert aufweist, wobei der zweite vorgegebene Zähigkeitswert größer als der erste vorgegebene Zähigkeitswert ist, wobei die ersten und zweiten (20, 22) Abschnitte miteinander verbunden sind, um eine tibiale Lagerkomponente (12) zu bilden, dadurch gekennzeichnet, daß entweder:
    (i) der erste Abschnitt (20) vernetztes Polyethylen aufweist und der zweite Abschnitt unvernetztes Polyethylen aufweist; oder
    (ii) der erste Abschnitt (20) verhältnismäßig hochvernetztes Polyethylen aufweist und der zweite Abschnitt verhältnismäßig gering vernetztes Polyethylen aufweist.
  4. Komponente nach Anspruch 3, wobei die ersten und zweiten Abschnitte (20, 22) in Sätzen von modularen ersten und zweiten Abschnitten (20, 22) vorgesehen sind, die selektiv intraoperativ miteinander verbunden werden können.
  5. Komponente nach Anspruch 3, wobei die ersten und zweiten Abschnitte (20, 22) zur Zeit der Herstellung dauerhaft miteinander verbunden werden.
  6. Komponente nach einem der Ansprüche 3 bis 5, wobei sie ferner mindestens einen Stift (32) aufweist und daß die ersten und zweiten Abschnitte (20, 22) durch den Stift miteinander verbunden sind, der sich in jeden der ersten (20) und zweiten (22) Abschnitte erstreckt.
  7. Komponente nach einem der Ansprüche 3 bis 5, wobei einer der ersten und zweiten Abschnitte (20, 22) einen Schwalbenschwanzvorsprung (34) aufweist und der andere der ersten und zweiten Abschnitte einen Schwalbenschwanzschlitz (36) aufweist und die ersten und zweiten Abschnitte (20, 22) miteinander verbunden sind, indem der Schwalbenschwanzvorsprung (34) mit dem Schwalbenschwanzschlitz (36) in Eingriff gebracht wird.
  8. Komponente nach einem der Ansprüche 3 bis 7, wobei der zweite Abschnitt (22) eine interkondyläre Erhöhung (26) und eine einheitliche Schale (14) aufweist, die sich von der interkondylären Erhöhung (26) erstreckt, wobei die Schale (24) eine Haltefläche zur Aufnahme des ersten Abschnitts aufweist.
  9. Implantat nach Anspruch 1, wobei die zweite Komponente (12) eine tibiale Komponente ist;
    die Gelenkverbindungseinrichtung erste und zweite Lagerabschnitte (20) aufweist, wobei jeder der ersten und zweiten Lagerabschnitte eine Gelenkfläche (24) aufweist; und
    die Einrichtung zur Ineingriffnahme der ersten Komponente ein interkondylärer Abschnitt (26) ist, der zwischen den ersten und zweiten Lagerabschnitten angeordnet ist, wobei der erste Lagerabschnitt, der zweite Lagerabschnitt (24) und der interkondyläre Abschnitt (22) drei getrennte Teilkomponenten bilden, die mechanisch miteinander verbunden sind, um eine einzige Komponente zu bilden.
  10. Implantat nach Anspruch 9, wobei der interkondyläre Abschnitt (22) eine tibiale Schale (16) aufweist, die eine tibiale Erhöhung (26) aufweist, wobei die ersten und zweiten Lagerabschnitte (20, 22) durch die Schale (14) aufgenommen sind, wobei die Erhöhung (26) dazwischen angeordnet ist.
EP04258149A 2004-01-02 2004-12-24 Mehrteiliges Bauteil für ein orthopädisches Implantat Expired - Lifetime EP1550421B1 (de)

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US751087 1996-11-15
US10/751,087 US7288115B2 (en) 2004-01-02 2004-01-02 Multipart component for an orthopaedic implant

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EP (2) EP1656909B1 (de)
JP (1) JP4575146B2 (de)
AT (2) ATE406853T1 (de)
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US7955393B2 (en) 2011-06-07
CA2476267A1 (en) 2005-07-02
EP1656909A1 (de) 2006-05-17
CA2476267C (en) 2008-12-02
DE602004016346D1 (de) 2008-10-16
EP1656909B1 (de) 2008-09-03
ES2287659T3 (es) 2007-12-16
US20080027555A1 (en) 2008-01-31
JP2005193038A (ja) 2005-07-21
US20050149198A1 (en) 2005-07-07
AU2004244651A1 (en) 2005-07-21
EP1550421A1 (de) 2005-07-06
DE602004007347T2 (de) 2008-03-06
ATE406853T1 (de) 2008-09-15
DE602004007347D1 (de) 2007-08-16
AU2004244651B2 (en) 2010-01-21
ATE366095T1 (de) 2007-07-15
JP4575146B2 (ja) 2010-11-04
US7288115B2 (en) 2007-10-30

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